HUMALOG KWIKPEN 100 U/ml, INJECTABLE SOLUTION

2. What you need to know before you use Humalog KwikPen

Do not use Humalog KwikPen

• If you think you are experiencing hypoglycaemia(low blood sugar levels). Later in this leaflet, it tells you how to deal with low blood sugar (see Section 3: If you use more Humalog than you need).

• If you are allergicto insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• At the pharmacy, always check the name and type of insulin on the label of the pen and the cartridge. Make sure you have been given the Humalog KwikPen that your doctor has prescribed for you.

• If your blood sugar levels are well controlled with your current insulin therapy, you may not get the usual warning symptoms of a low blood sugar. Later in this leaflet, these warning symptoms are listed.

You must plan carefully when to eat, when to exercise and how much to exercise. You must also keep a close check on your blood sugar levels by having regular blood glucose tests.

• Some patients who have changed from animal insulin to human insulin have reported that the early warning symptoms of low blood sugar are less pronounced or different. If you are prone to low blood sugar or have difficulty recognising the warning signs, please discuss this with your doctor.

• If you answer YESto any of the following questions, tell your doctor, pharmacist or diabetes educator
• • Have you recently become unwell?

• • Do you have liver or kidney problems?
  • Are you doing more exercise than usual?
• The amount of insulin you need may change if you drink alcohol.

• If you are going abroad, tell your doctor, pharmacist or diabetes educator. The time difference between countries may mean that you have to adjust your insulin routine and diet.

• Some patients with long-standing type 2 diabetes and heart disease or a previous stroke who were treated with pioglitazone and insulin developed heart failure. Tell your doctor as soon as possible if you get signs of heart failure such as difficulty breathing, rapid weight gain or localised swelling (oedema).
• It is not recommended that blind or visually impaired patients use this pen without assistance from a trained person.

Other medicines and Humalog KwikPen

Your insulin needs may change if you are taking

• oral contraceptives,

• corticosteroids,

• thyroid hormone replacement therapy,

• oral hypoglycaemic medicines,

• aspirin,

• sulfa antibiotics,

• octreotide,

• beta-2 stimulants (such as ritodrine, salbutamol or terbutaline),

• beta-blockers, or

• certain antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

• danazol,

• certain angiotensin-converting enzyme (ACE) inhibitors (such as captopril, enalapril), and

• angiotensin II receptor blockers.

Tell your doctor if you are using, have recently used or might use any other medicines, including those not prescribed by a doctor (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or breast-feeding, thinking of becoming pregnant or planning to breast-feed? The amount of insulin you need usually decreases during the first three months of pregnancy and increases during the last six months. If you are breast-feeding, you may need to adjust your insulin dose or diet. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Your ability to concentrate or react may be reduced if you have low blood sugar. Be careful when driving a car or operating machinery. You should contact your doctor for advice on driving if you

• have frequent episodes of low blood sugar

• have difficulty recognising the warning signs of low blood sugar

Humalog KwikPen contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.

3. How to use Humalog KwikPen

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor again. To prevent possible transmission of disease, each pen must be used by you only, even if the needle is changed.

Dose

• Humalog should normally be given shortly before a meal. If necessary, it can be given shortly after a meal. However, your doctor will tell you exactly how much to use, when to use it and how often. These instructions are specific to you and your diabetes. Follow them exactly and visit your diabetes clinic regularly.

• If you change the type of insulin you use (for example from animal or human insulin to a product with Humalog), you may need to use a larger or smaller dose than before. This may only be for the first injection or it may need to be continued for several weeks or months.

• Humalog KwikPen is only intended for injection under the skin. If you need to inject insulin by another method, ask your doctor.

Preparing Humalog KwikPen

• Humalog is already dissolved in water, so you do not need to mix it. However, onlyuse it if it looks like water. It must be clear, have no colour and not contain any solid particles. Check this before you inject each dose.

Preparing the KwikPen (please read the user manual)

• First, wash your hands.

• Read the instructions on how to use your pre-filled pen. Follow the instructions carefully. Here are some reminders.

• Use a new needle. (Needles are not included).

• Purge your KwikPen before each use. This checks that the insulin is coming out and that air bubbles are removed from the KwikPen. You may still see small air bubbles. These are harmless. But if the air bubble is too large, the dose of the injection may be slightly less accurate.

Injecting Humalog

• Before you inject, clean your skin as you have been instructed. Inject under the skin, as you have been instructed. Do not inject directly into a vein. After the injection, leave the needle in the skin for 5 seconds to make sure you have injected all the insulin. Do not rub the area where you have just injected. Make sure you inject at least 1 cm away from where you last injected and rotate the sites as you have been instructed. The injection of Humalog will always work more quickly than soluble human insulin, no matter where you inject it (upper arm, thigh, buttock or abdomen).

• Do not inject Humalog into a vein. Inject Humalog as your doctor or diabetes educator has taught you. Only your doctor can give you Humalog into a vein. Your doctor will only do this in special circumstances such as surgery or if you are ill and your blood sugar levels are too high.

After the injection

• As soon as you have finished injecting, remove the needle from the KwikPen using the outer needle shield. This will keep the insulin sterile and prevent contamination. It will also prevent air entering the KwikPen and the needle becoming blocked. Do not share needles.Do not share your pen. Put the pen cap back on the pen.

Further injections

• Each time you use the KwikPen, use a new needle. Before each injection, remove any air bubbles. You can see how much insulin is left by looking at the scale on the cartridge. The scale shows the number of units of 1 ml of insulin.

• Do not mix any other insulin with the insulin in the KwikPen. When the KwikPen is empty, it must not be used again. Dispose of it carefully; ask your pharmacist or diabetes educator for advice.

Using Humalog in an insulin infusion pump

• Humalog KwikPen is only intended for injection under the skin. Do not use it in an infusion pump. If you need to use an infusion pump, other Humalog presentations are available. Ask your doctor if you need to inject insulin by another method.

If you use more Humalog than you need

If you use more Humalog than you need, you may get low blood sugar. Check your blood sugar levels.

If your blood sugar levels are low (mild hypoglycaemia), eat glucose tablets, sugar or a sugary drink. Then eat a snack, such as a biscuit or a sandwich, as your doctor has advised, and rest. This usually helps to recover from a mild attack of low blood sugar or an overdose of insulin. If you do not feel better, contact your doctor or hospital.

If you forget to use Humalog

If you use less Humalog than you need, you may get high blood sugar. Check your blood sugar levels.

If you are not sure, or if you have missed a dose, consult your doctor or pharmacist. If low blood sugar (hypoglycaemia) or high blood sugar (hyperglycaemia) are not treated, they can be very serious and even cause unconsciousness or death (see section 4 “Possible side effects”).

Three simple measuresto prevent low blood sugar or high blood sugar are:

• Always carry some spare Humalog and needles or a spare pen and cartridges with you, in case you lose or damage your pen or it gets empty.

• Always carry something to show you are diabetic.

• Always carry some sugar with you.

If you stop using Humalog

If you use less Humalog than you need, you may get high blood sugar. Do not change your insulin unless your doctor has told you to. If you have any other questions or concerns about your diabetes or your treatment, talk to your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Systemic allergy is rare (≥1/10,000 to <1>

If you think you are suffering from this type of allergy with Humalog, talk to your doctor immediately.

Localized allergy is frequent (≥1/100 to <1>

Lipodystrophy (the skin becomes thicker or a kind of hole forms) is infrequent (≥1/1,000 to <1>

There have been cases of edema (e.g., swelling in the arms, ankles; fluid retention), especially at the beginning of insulin treatment or during a change in treatment to improve blood sugar control.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Common Diabetes Problems

1. Hypoglycemia

Hypoglycemia (low blood sugar level) means that you do not have enough sugar in your blood.

It can be caused because:

• you have taken too much Humalog or any other type of insulin;

• you have skipped a meal, delayed it, or changed your diet;

• you have worked too much or done too much exercise immediately before or after a meal;

• you have an infection or are sick (especially diarrhea or vomiting);

• there have been changes in your insulin needs; or

• you have worsened kidney or liver disease.

Alcohol and certain medications can affect your blood sugar levels.

The first symptoms of low blood sugar usually appear suddenly and are accompanied by:

Until you are sure you can recognize the warning symptoms, avoid situations (e.g., driving a car) where you or others could be in danger if hypoglycemia occurs.

1. Hyperglycemia and Diabetic Ketoacidosis

Hyperglycemia (too much sugar in the blood) means that the body does not have enough insulin. Hyperglycemia can be caused because:

• you have not taken Humalog or any other type of insulin;

• you have taken less insulin than your doctor prescribed;

• you have eaten much more than your diet allows; or

• you have a fever, an infection, or emotional stress.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms appear slowly, over many hours or several days. Among these symptoms are:

Severe symptoms are heavy breathing and rapid pulse. Get medical assistance immediately.

1. Illnesses

If you are sick, especially if you have nausea or vomiting, the amount of insulin you need may vary. Even if you are not eating as usual, you still need to receive insulin.Have your urine or blood analyzed, follow the instructions you have been given for when you are sick, and call your doctor.

5. Storage of Humalog KwikPen

Before the first use, store Humalog KwikPen in the refrigerator (between 2°C and 8°C). Do not freeze.

Keep your Humalog KwikPen in use at room temperature (below 30°C) and discard it after 28 days. Do not leave it near any heat source or in the sun. Do not store the KwikPen that you are using in the refrigerator. The KwikPen should not be stored with the needle attached.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the label and packaging. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice that it has a color or contains solid particles. Onlyuse it if its appearance is like water. Check that this is the case before each injection.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Humalog KwikPen 100 units/ml injectable solution

• The active ingredient is insulin lispro. Insulin lispro is manufactured in the laboratory by a process of "recombinant DNA technology". It is a modified form of human insulin and, therefore, differs from other human insulins and animal-derived insulins. Insulin lispro is closely related to human insulin, which is a natural hormone produced by the pancreas.

• The other components are m-cresol, glycerol, disodium phosphate heptahydrate, zinc oxide, and water for injectable preparations. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

Appearance of the Product and Package Contents

Humalog KwikPen 100 units/ml injectable solution is a sterile, transparent, colorless, aqueous solution and contains 100 units of insulin lispro in each milliliter of injectable solution (100 units/ml). Each Humalog KwikPen contains 300 units (3 milliliters). Humalog KwikPen is presented in a package of 5 pre-filled pens or in a multiple package consisting of 2 packages of 5 pre-filled pens. Not all presentations may be marketed. The Humalog 100 units/ml contained in your pre-filled pen is the same as the Humalog 100 units/ml presented in individual Humalog 100 units/ml cartridges. The KwikPen simply contains a cartridge inside. When the pre-filled pen is empty, it cannot be reused.

Marketing Authorization Holder and Manufacturer

Humalog KwikPen 100 units/ml injectable solution is manufactured by:

• Lilly France, S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

• Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The marketing authorization holder is Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Prospectus:

USER MANUAL

The text of the user manual is included at the end.

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.